Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty

The Effect of Dexmedetomidine on Postoperative Recovery in Elderly Patients With Femoral Neck Fracture Undergoing Hip Hemi-arthroplasty

Hip fractures incidence grows rapidly with the aging of the population. After indicated surgical treatment, hip fracture patients experience high rates of postoperative complications, postoperative delirium (PD), postoperative cognitive dysfunction (POCD), leading to poor postoperative recovery during hospitalization, which can cause disability, distress for both patients and their families, are associated with other medical complications and account for significant additional health care costs. We currently use dexmedetomidine in elderly patients with hip fractures undergoing hip hemi-arthroplasty in order to improve postoperative recovery and prevent and treating PD and POCD.

Dexmedetomidine is a drug used for sedation in critically ill patients that provides some pain relief and controls the bodies response to stress. The sedation produced by dexmedetomidine appears more similar to natural sleep than any other drug used for anesthesia and postoperative sedation. Data suggesting that dexmedetomidine can prevent delirium following cardiac surgery and the developing understanding of the causes of PD and POCD suggest that dexmedetomidine will be particularly effective.

Study Overview

• Status: Unknown
• Conditions: Postoperative Complications; Inflammatory Response; Postoperative Delirium; Postoperative Cognitive Dysfunction; Femoral Neck Fractures
• Intervention / Treatment: Procedure: hip arthroplasty; Drug: Total Intravenous Anesthesia and Peripheral nerve blocks

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100853
    • Recruiting
    • Anesthesia and Operation Center, Chinese People's Liberation Army General Hospital
    • Contact: Yuan Weixiu, Ph.d; Phone Number: 0086-10-66938052; Email: yuanweixiu301@126.com
    • Sub-Investigator: Gong Maowei, MD
    • Sub-Investigator: Zhao Ying, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria

• Age > 75years old
• Patients with femoral neck fractures
• Undergoing hip hemi-arthroplasty surgery
• American Society of Anesthesiologists (ASA) physical status II-IV
• MoCA being more than 23

Exclusion Criteria

• Patient refusal to participate in the study
• Patient refusal or failure of regional block
• allergic to local anesthetics or general anesthetics
• history of opioid dependence
• contraindications to nerve blocks (coagulation defects, infection at puncture site, preexisting neurological deficits in the lower extremities)
• current severe psychiatric disease or alcoholism or drug dependence
• severe visual or auditory disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexmedetomidine; Dexmedetomidine in dex group is administered as 1ug/kg by intravenous infusion 10 min and then 0.6 ug/kg until 30 minutes before the operation finishes.	Procedure: hip arthroplasty; Every patient with femoral neck fractures must undergo hip hemi-arthroplasty.; Drug: Total Intravenous Anesthesia and Peripheral nerve blocks; Every patient receives Peripheral nerve blocks and Total Intravenous Anesthesia with propofol
Placebo Comparator: Saline; Participants in con group receive placebo(saline) as the same dose at the same time as dex group.	Procedure: hip arthroplasty; Every patient with femoral neck fractures must undergo hip hemi-arthroplasty.; Drug: Total Intravenous Anesthesia and Peripheral nerve blocks; Every patient receives Peripheral nerve blocks and Total Intravenous Anesthesia with propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative cognitive dysfunction(POCD)	POCD is assessed by Montreal Cognitive Assessment(MoCA), which was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration,executive functions, memory, language,visuoconstructional skills, conceptual thinking,calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points; a score of 26 or above is considered normal.	7days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative recovery	The postoperative recovery is assessed by the Post-operative Quality Recovery Scale (PQRS),which is a research tool designed to measure postoperative quality of recovery in multiple domains and over multiple time periods. Recovery domains include physiological, emotive (depression and anxiety), nociceptive (pain and nausea), cognitive, activities of daily living (ADL), and overall patient perspective (including satisfaction).	7days
Postoperative Delirium(PD)	The postoperative Delirium is assessed by the Confusion Assessment Method (CAM)	72 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative complications		7 days
perioperative opioid consumption	Intraoperative and postoperative opioid consumption were calculated between the two groups.	3 days
IL-6 and C-reacting protein		7 days
MB isoenzyme of creatine kinase and blood sugar		7 days

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Investigators: Study Chair: zhang hong, ph.d, Anesthesia and Operation Center, Chinese People's Liberation Army General Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): February 1, 2014
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: August 21, 2013
• First Submitted That Met QC Criteria: August 29, 2013
• First Posted (Estimate): September 4, 2013

Study Record Updates

• Last Update Posted (Estimate): September 10, 2013
• Last Update Submitted That Met QC Criteria: September 7, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Fractures, Bone; Wounds and Injuries; Neurocognitive Disorders; Leg Injuries; Cognition Disorders; Femoral Fractures; Hip Injuries; Hip Fractures; Cognitive Dysfunction; Postoperative Cognitive Complications; Postoperative Complications; Femoral Neck Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: Dex-THR